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To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors

Primary Purpose

Dyslipidemias

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Atorvastatin 20mg

Atorvastatin 20 mg + CKD-519 50 mg

Atorvastatin 20 mg + CKD-519 100 mg

Atorvastatin 20 mg + CKD-519 200 mg

Rosuvastatin 10 mg

Rosuvastatin 10 mg + CKD-519 100 mg

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Dyslipidemia, CETP Inhibitors, Hyperlipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 80 years.
Dyslipidemia with LDL-C
- At screening if untreated: 100 to 190 mg/dL
- At screening if treated with statins or other lipid-lowering drugs: 100 to 170 mg/dL
- At start of double-blind treatment: 100 to 190 mg/dL.
HDL-C <45 mg/dL (males) or <50 mg/dL (females).
Fasting TG <400 mg/dL.
Presence of the following conditions is permitted but not mandatory, at the discretion of the investigator:
- Treated and stable coronary heart disease without acute events in the past 3 months and stable, state-of-the-art medication.
- Treated and stable carotid artery disease or peripheral arterial disease on stable, standard medication for the past 3 months
- Treated and stable Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤9.5%.
Willing and able to sign the informed consent form (ICF).

Exclusion Criteria:

Chronic heart failure as defined by New York Heart Association classes III and IV.
Uncontrolled cardiac arrhythmias.
Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1.
Stroke or transient ischemic attack within 3 months before Visit 1.
Uncontrolled hypertension.
Clinically significant laboratory abnormalities
- Aspartate aminotransferase or alanine aminotransferase >2 times upper limit of normal range
- Bilirubin >1.5 times upper limit of normal range
- Creatine kinase >2 times upper limit of normal range.
Any active nephropathy or estimated glomerular filtration rate <60 mL/min/1.73m2 or on kidney dialysis.
Poorly controlled (thyroid-stimulating hormone [TSH] >2 times upper limit of normal) hyperthyroidism.
Homozygous familial hypercholesterolemia.
Intolerance or hypersensitivity to atorvastatin or rosuvastatin.
Prior treatment with any CETP inhibitor.
Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.

Sites / Locations

Not provided

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Atorvastatin 20 mg

Atorvastatin 20 mg + CKD-519 50 mg

Atorvastatin 20 mg + CKD-519 100 mg

Atorvastatin 20 mg + CKD-519 200 mg

Rosuvastatin 10 mg

Rosuvastatin 10 mg + CKD-519 100 mg

Arm Description

To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks

To administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks

To administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks

To administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks

To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks

To administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks

Outcomes

Primary Outcome Measures

Percentage change from baseline (Visit 3) in LDL-C

Secondary Outcome Measures

Percentage change from baseline in HDL-C

Percentage change from baseline in concentration of HDL particles (HDL-P)

Change from baseline in size of HDL particles (HDL-P)

Percentage change from baseline in LDL-C

Change in concentration from baseline in LDL-C

Change in concentration from baseline in HDL-C

Percentage change from baseline in total cholesterol, TG, and non-HDL-C

Change in concentration from baseline in total cholesterol, TG, and non-HDL-C

Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)

Change in concentration from baseline in Apo B, Apo A1, and Apo E

Percentage change from baseline in lipoprotein(a) (Lp-a)

Change in concentration from baseline in Lp-a

Change in concentration from baseline in high-sensitivity C-reactive protein at

Full Information

NCT ID

NCT02977065

First Posted

November 27, 2016

Last Updated

November 5, 2018

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02977065

Brief Title

To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors

Official Title

Multicenter, Parallel-group, Double-blind, Randomized, Active-controlled, Dose-ranging Study to Assess the Safety, Efficacy, and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors, in Subjects With Dyslipidemia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 23, 2017 (Actual)

Primary Completion Date

December 30, 2017 (Actual)

Study Completion Date

January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.

Detailed Description

The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519, administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias

Keywords

Dyslipidemia, CETP Inhibitors, Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin 20 mg

Arm Type

Active Comparator

Arm Description

To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks

Arm Title

Atorvastatin 20 mg + CKD-519 50 mg

Arm Type

Experimental

Arm Description

To administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks

Arm Title

Atorvastatin 20 mg + CKD-519 100 mg

Arm Type

Experimental

Arm Description

To administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks

Arm Title

Atorvastatin 20 mg + CKD-519 200 mg

Arm Type

Experimental

Arm Description

To administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks

Arm Title

Rosuvastatin 10 mg

Arm Type

Active Comparator

Arm Description

To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks

Arm Title

Rosuvastatin 10 mg + CKD-519 100 mg

Arm Type

Experimental

Arm Description

To administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 20mg

Other Intervention Name(s)

Lipitor 20mg

Intervention Description

PO daily for 4weeks

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 20 mg + CKD-519 50 mg

Other Intervention Name(s)

Lipitor 20mg

Intervention Description

PO daily for 4weeks

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 20 mg + CKD-519 100 mg

Other Intervention Name(s)

Lipitor 20mg

Intervention Description

PO daily for 4weeks

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 20 mg + CKD-519 200 mg

Other Intervention Name(s)

Lipitor 20mg

Intervention Description

PO daily for 4weeks

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 10 mg

Other Intervention Name(s)

Crestor 10mg

Intervention Description

PO daily for 4weeks

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 10 mg + CKD-519 100 mg

Other Intervention Name(s)

Crestor 10mg

Intervention Description

PO daily for 4weeks

Primary Outcome Measure Information:

Title

Percentage change from baseline (Visit 3) in LDL-C

Time Frame

at Week 4

Secondary Outcome Measure Information:

Title

Percentage change from baseline in HDL-C

Time Frame

at Weeks 2 and Week 4

Title

Percentage change from baseline in concentration of HDL particles (HDL-P)

Time Frame

at Weeks 2 and 4

Title

Change from baseline in size of HDL particles (HDL-P)

Time Frame

at Weeks 2 and 4

Title

Percentage change from baseline in LDL-C

Time Frame

at Week 2

Title

Change in concentration from baseline in LDL-C

Time Frame

at Weeks 2 and 4

Title

Change in concentration from baseline in HDL-C

Time Frame

at Weeks 2 and 4

Title

Percentage change from baseline in total cholesterol, TG, and non-HDL-C

Time Frame

at Weeks 2 and 4

Title

Change in concentration from baseline in total cholesterol, TG, and non-HDL-C

Time Frame

at Weeks 2 and 4

Title

Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)

Time Frame

at Weeks 2 and 4

Title

Change in concentration from baseline in Apo B, Apo A1, and Apo E

Time Frame

at Weeks 2 and 4

Title

Percentage change from baseline in lipoprotein(a) (Lp-a)

Time Frame

at Weeks 2 and 4

Title

Change in concentration from baseline in Lp-a

Time Frame

at Weeks 2 and 4

Title

Change in concentration from baseline in high-sensitivity C-reactive protein at

Time Frame

at Weeks 2 and 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 80 years. Dyslipidemia with LDL-C At screening if untreated: 100 to 190 mg/dL At screening if treated with statins or other lipid-lowering drugs: 100 to 170 mg/dL At start of double-blind treatment: 100 to 190 mg/dL. HDL-C <45 mg/dL (males) or <50 mg/dL (females). Fasting TG <400 mg/dL. Presence of the following conditions is permitted but not mandatory, at the discretion of the investigator: Treated and stable coronary heart disease without acute events in the past 3 months and stable, state-of-the-art medication. Treated and stable carotid artery disease or peripheral arterial disease on stable, standard medication for the past 3 months Treated and stable Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤9.5%. Willing and able to sign the informed consent form (ICF). Exclusion Criteria: Chronic heart failure as defined by New York Heart Association classes III and IV. Uncontrolled cardiac arrhythmias. Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1. Stroke or transient ischemic attack within 3 months before Visit 1. Uncontrolled hypertension. Clinically significant laboratory abnormalities Aspartate aminotransferase or alanine aminotransferase >2 times upper limit of normal range Bilirubin >1.5 times upper limit of normal range Creatine kinase >2 times upper limit of normal range. Any active nephropathy or estimated glomerular filtration rate <60 mL/min/1.73m2 or on kidney dialysis. Poorly controlled (thyroid-stimulating hormone [TSH] >2 times upper limit of normal) hyperthyroidism. Homozygous familial hypercholesterolemia. Intolerance or hypersensitivity to atorvastatin or rosuvastatin. Prior treatment with any CETP inhibitor. Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyung-Mi Park, PhD

Organizational Affiliation

Chong Kun Dang Pharm.

Official's Role

Study Director

Facility Information:

Facility Name

Not provided

City

Adelaide

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors

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